Senior Analytical Development Scientist
- Reporting to the Principal Scientist, the senior analytical development scientist will be the site analytical science expert/ lead. The successful candidate will support site analytical challenges, work on life cycle management teams and support process development activities.
- Site gate keeper and analytical expert - will be expected to be close to all transfers, developments and clearly identify any challenges with analytical methods upfront, along with ways to improve.
- A technical specialist in protein analytics, including release testing, more complex and advanced analytical technologies
- Work with QC colleagues:
- In the development/ transfer of analytical methods.
- In the troubleshooting of analytical methods (biophysical, physical characterisation and release methods for biopharmaceuticals).
- As a point of contact across sites for technical issues associated with analytics.
- Sit on and work with global analytical life cycle management (ALCM) teams
- Relationships with site leadership, site QC, QA, internal and global Development Sciences, MSAT, R&D.
- Has strong understanding of product characteristics and impacts of manufacturing process on CQA's.
- Will propose improved ways of characterising proteins and physical attributed of drug substance and drug product in support of fill finish process development.
- Mentor other scientists on more advanced or complex theory & equipment technology.
Desired Skills / Knowledge
- Demonstrated expertise in Protein Science is a must.
- Strong understanding of biopharmaceuticals, protein science analytics is a requirement.
- SME expertise in a given area(s) such as, Analytical Method Development, Analytical Characterisation, Biophysical & Physical Characterisation, Release Analytics, Analytical Technology.
- Proficient in analytical science, technologies, techniques and framework to enable successful process development, method development & transfer; relates efforts and approaches to best-practices & business asks; capable of working on a new analytical technology platforms.
- Experience with liquid and solid state analytical characterisation and release testing
- Analytical Characterisation (not limited to the following):
- Protein Characterisation tools such as CD, FTIR, Fluorescence Spectroscopy, HPLC; SDS-PAGE, ELISA, DCS and other techniques
- Solid State Characterisation such as DSC, Karl Fisher;
- Experienced with regulatory bodies and writing pharmaceutical development sections of a product filing.
- Has demonstrated understanding and application of relevant Compendial and Pharmacopeial standards to their specification of interest.
- Can review on-going product data (e.g. Periodic Product Performance, Change Control, Process Control Strategy, QC stability trends, Development studies) and make recommendations to changes/enhancements to existing specifications based on risk assessment techniques
- Can lead others in the completion of Technology transfer technical deliverables; can act as Sending or Receiving Unit Technical Lead
- Proficient in the application of Drug Development knowledge to one or more products; can work on new and/or existing products.
- Provides guidance and mentoring to site teams as appropriate.
- Can understand results, trends, investigations, can troubleshoot method and equipment issues, working logically and systematically to resolve problem.
- Can perform complex data trending and analysis.
- Present ideas in a manner that will gain buy-in from major cross functional stakeholders to facilitate implementation of solutions. Comfortable to present at industry forums and answer questions as they arise. May prepare industry papers as required and appropriate.
- Can present findings of work professionally & objectively.
- Has experience of interactions with other scientists within network to share best-practice/lessons learnt
- Skilled problem solver & Excellent Communication Skills
MSc or equivalent
Preferred PhD in related science field
Relevant to protein science and analytics
Minimum 7 - 10 years' experience in a relevant pharmaceutical or biopharmaceutical role
Call Roberta at 016455250 or email